Surgical Stapling Apparatus Having a Wound Closure Material Applicator Assembly

ABSTRACT

A surgical stapling apparatus includes a staple anvil and a staple cartridge having a working surface, one or more rows of individual staple slots formed in the working surface, a knife track formed along a length of the working surface, and a plurality of surgical staples individually disposed within the individual staple slots. The apparatus further includes an actuation sled having a knife and being configured and adapted to movably position the knife axially within the knife track. The apparatus also includes a wound closure material applicator assembly having a needle secured to the knife to dispense a quantity of wound closure material along a length of the knife track as the actuation sled and knife are moved therealong.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.provisional Application Ser. No. 60/379,971 filed on May 10, 2002, theentire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical staplers, and moreparticularly, to a surgical stapling apparatus for applying a pluralityof surgical fasteners to body tissue and having a wound closure materialapplicator assembly for dispensing a quantity of wound closure materialor components thereof, at least along a knife cut line and/or a stapleline.

2. Background of Related Art

Surgical procedures requiring cutting of tissue can result in bleedingat the site of the cut. Various techniques have been developed tocontrol bleeding with varying degrees of success, such as, for example,suturing, applying clips to blood vessels, and using surgical fasteners,as well as electrocautery and other tissue healing techniques.

Surgical instruments using surgical fasteners entail grasping orclamping tissue between opposing jaw structure and then joining thetissue by employing the surgical fasteners. These instruments are wellknown in the art. In some instruments, a knife is provided to cut thetissue, which has been joined by the fasteners. The fasteners aretypically in the form of surgical staples however, two part polymericfasteners can also be utilized.

Instruments for this purpose can include two elongated or circularmembers, which are respectively used to capture or clamp tissue.Typically, one of the members carries a cartridge, which houses aplurality of staples arranged in at least two lateral rows while theother member carries an anvil, which defines a surface for forming thestaple legs as the staples are driven from the cartridge. Where two partfasteners are used, one of the members carries a cartridge which housesone half of a fastener while the other member carries the second part ofthe fastener, e.g., the mating part, which halves are configured andadapted to to be held together upon approximation. Typically, thestapling operation is effected by a driving member, which travelslongitudinally through the cartridge carrying member, with the drivingmember acting upon pushers, which engage the staples for sequentiallyejecting them from the cartridge. A knife can be provided which travelsbetween the staple rows to longitudinally cut (i.e., form a knife cutline) and/or open the stapled tissue between the rows of staples.Usually, but not always, the knife is associated with or travels withthe staple driving member. Such instruments are disclosed in U.S. Pat.Nos. 3,079,606 and 3,490,675, the entire contents of which areincorporated herein by reference.

A later stapler disclosed in U.S. Pat. No. 3,499,591, the entirecontents of which are incorporated herein by reference, applies a doublerow of staples on each side of the incision or the knife cut line. Thisis accomplished by providing a cartridge assembly in which a cam membermoves through an elongate guide path between two sets of staggeredstaple carrying grooves. Staple drive members are located within thegrooves and are positioned in such a manner so as to be contacted by thelongitudinally moving cam to effect ejection of the staples. Otherexamples of staplers are disclosed in U.S. Pat. Nos. 4,429,695,5,065,929, and 5,156,614, the entire contents of which are incorporatedherein by reference.

Electrocautery devices are preferred in certain surgical procedures foreffecting improved hemostasis by heating tissue and blood vessels usingthermogenic energy, preferably radiofrequency energy, to causecoagulation or cauterization. Monopolar devices utilize one electrodeassociated with a cutting or cauterizing instrument and a remote returnelectrode, usually adhered externally to the patient. Bipolarinstruments utilize two electrodes and the cauterizing current isgenerally limited to tissue between the two electrodes of a tissuetreating portion (e.g., end effector) of an instrument.

Even though stapling apparatus and electrocauterizing apparatus arerespectively generally well suited to control bleeding along the knifecut line, other techniques are herein envisioned for being used inconjunction with these techniques.

Therefore, it is an aspect of the invention to provide a surgicalstapling apparatus for providing general hemostasis, tissue joining orwelding, and also a wound closure material, for example, for providingadditional hemostasis along a cut line formed by a knife or othercutting means and/or along a staple line of the surgical staplingapparatus to reduce or prevent bleeding along the cut line and/or stapleline.

SUMMARY

This present disclosure relates to surgical stapling apparatus having awound closure material applicator for applying a plurality of surgicalfasteners to body tissue and dispensing a quantity of wound closurematerial or components thereof, along a staple line and/or a knife cutline.

According to one aspect of the present disclosure, a surgical staplingapparatus for enhancing one or more properties of body tissue that is oris to be repaired or joined is provided. The surgical stapling apparatusincludes a staple anvil positioned on a distal end of the staplingapparatus and having a longitudinal knife track and a staple cartridgepositioned adjacent a distal end of the stapling apparatus, the staplecartridge and staple anvil being juxtaposable relative to each other.The staple cartridge includes a plurality of surgical staplesindividually disposed within individual staple slots formed in rows inthe staple cartridge and having a longitudinal knife slot.

The surgical stapling apparatus includes a driving member for firing thesurgical staples from the individual staple slots and against the stapleanvil, a knife blade structure including a knife blade receivable in andaxially movable along the knife track and knife slot, and a woundclosure material applicator assembly operatively associated with thestapling apparatus. The wound closure material applicator assemblyincludes a channel with an orifice, and a conduit in fluid communicationwith the channel, wherein axial movement of the knife blade structurethrough the knife track and knife slot axially advances the knife bladestructure to permit the orifice to dispense wound closure material fromthe orifice into an area between the staple anvil and the staplecartridge.

It is envisioned that the applicator assembly further includes at leastone reservoir in fluid communication with the conduit, the at least onereservoir containing a wound closure material therein. The drivingmember can include an actuation sled and the knife blade structure ispart of the actuation sled. The knife blade structure preferablyincludes a needle having the orifice.

The wound closure material can be an astringent, a sulfate of aluminum,an adhesive, a hemostat and/or a sealant.

The reservoir can be compressible. Compression of the reservoir cancause the wound closure material to be dispensed from a needle of theapplicator assembly.

The orifice of the needle can be oriented in at least one of a proximal,distal, downward and upward direction. Preferably, the needle has a tipand the orifice is located at the tip. The needle can include aplurality of orifices oriented in at least one of a proximal, distal,downward and upward direction.

The conduit is preferably extendable through at least a portion of thestaple cartridge.

The needle can be secured to the knife blade structure. As such, theneedle can be adapted to dispense the wound closure material into atleast an area near the knife blade and/or into at least an area behindthe knife blade.

According to a further aspect of the present disclosure, a surgicalstapling apparatus for enhancing one or more properties of body tissuethat is or is to be repaired or joined is provided. The surgicalstapling apparatus includes a staple anvil positioned on a distal end ofthe stapling apparatus and having a longitudinal knife track and astaple cartridge positioned adjacent a distal end of the staplingapparatus, the staple anvil and staple cartridge being juxtaposablerelative to each other. The staple cartridge includes a working surface,one or more rows of individual staple slots formed in the workingsurface, a knife slot formed along a length of the working surface, anda plurality of surgical staples individually disposed within theindividual staple slots.

The surgical stapling apparatus includes a driving member translatablyreceivable in the staple cartridge for firing the surgical staples fromthe individual staple slots and against the staple anvil, the drivingmember including an actuation sled having a knife operatively connectedthereto, the actuation sled being configured and adapted to position theknife to be axially moveable within the track and the knife slot.

The surgical stapling apparatus further includes a wound closurematerial applicator assembly including an applicator having an orificeand configured to dispense a quantity of wound closure material from theorifice as the knife moves along a length of the knife slot.

The wound closure material applicator can include a needle having anorifice and secured to a portion of the actuation sled, wherein theneedle directs the dispensation of wound closure material through theorifice, and a conduit in fluid communication with the needle fordelivering the quantity of wound closure material to the needle. Thewound closure material applicator assembly can further include areservoir, containing at least one quantity of wound closure material,in fluid communication with the conduit.

The quantity of wound closure material can be an astringent, anadhesive, a hemostat, and a sealant.

The reservoir can be compressible. Compression of the reservoir causesthe wound closure material to be dispensed from the needle of theapplicator.

The needle has a tip with the orifice and the tip of the needle isoriented in at least one of a proximal, distal, downward and upwarddirection. The needle includes a plurality of orifices oriented in atleast one of a proximal, distal, downward and upward direction. Theorifice is adapted to spray a mist of the wound closure material nearand/or behind the knife.

According to a further aspect of the present disclosure, a surgicalstapling apparatus for enhancing one or more properties of body tissuethat is or is to be repaired or joined, wherein the surgical staplingapparatus includes a staple anvil positioned on a distal end of thestapling apparatus, a staple cartridge positioned adjacent a distal endof the stapling apparatus, the staple cartridge including a workingsurface defining a knife slot formed along a length thereof, a drivingmember translatably receivable in the staple cartridge and including anactuation sled having a knife structure operatively connected theretoand positioned within the knife slot, is provided.

The improvement includes a wound closure material applicator assemblyconfigured to dispense a quantity of wound closure material as the knifestructure moves along a length of the knife slot.

It is envisioned that the wound closure material applicator includes aneedle secured to the actuation sled, wherein the needle directs thedispensation of wound closure material, and a conduit in fluidcommunication with the needle for delivering the quantity of woundclosure material to the needle. It is further envisioned that the needleis secured to the knife.

It is contemplated that the wound closure material applicator furtherincludes a reservoir, containing the quantity of wound closure material,in fluid communication with the conduit.

The quantity of wound closure material is an astringent, an adhesive, ahemostat and/or a sealant.

The reservoir can be compressible. Accordingly, compression of thereservoir causes the wound closure material to be dispensed from theneedle. The reservoir can be in the form of a syringe. The syringe caninclude two chambers each containing a different wound closure material.Alternatively, the syringe includes two chambers each containing acomponent of a wound closure material, wherein the wound closurematerial is activated upon combination of the two components of thewound closure material.

It is contemplated that the needle directs wound closure material onto,in front of, behind or to the sides of the knife. It is alsocontemplated that advantageously, in combination with any of the aboveaspects of the invention, the conduit can have one or more holes thereinto dispense wound closure material onto tissue disposed between theanvil and the cartridge.

Further features of the surgical apparatus of the invention will becomemore readily apparent to those skilled in the art from the followingdetailed description of the apparatus taken in conjunction with thedrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the surgical stapling apparatus of the inventionwill be described hereinbelow with reference to the drawings wherein:

FIG. 1A is a perspective view of a surgical stapling apparatus having awound closure material applicator assembly constructed in accordancewith a preferred embodiment, with the clamping handle of the apparatusdisposed in an upright open position;

FIG. 1B is a perspective view of the surgical stapling apparatusillustrated in FIG. 1A with the clamping handle disposed in a closedposition;

FIG. 2A is an exploded perspective view of the surgical staplingapparatus of FIG. 1A;

FIG. 2B is a perspective view of a surgical stapling apparatus having awound closure material applicator assembly constructed in accordancewith another preferred embodiment;

FIG. 2C is a perspective view of a surgical stapling apparatus having awound closure material applicator assembly constructed in accordancewith another preferred embodiment;

FIG. 3 is a perspective view of a cartridge half-section of the surgicalstapling apparatus of FIG. 1A;

FIG. 4A is a top plan view of a retention channel of the surgicalstapling apparatus of FIG. 1A;

FIG. 4B is a side elevational view of the retention channel shown inFIG. 4A;

FIG. 4C is a perspective view of the retention channel of FIGS. 4A and4B with the disposable loading unit retained therein;

FIG. 5A is an enlarged perspective view, with parts separated, of thedisposable loading unit and actuation assembly of the surgical staplingapparatus of FIG. 1A;

FIG. 5B is a cross-sectional view of the indicated area in FIG. 5Ashowing the engagement of the cartridge lip and the retention channel;

FIG. 6A is a perspective view of the actuation sled of the disposableloading unit shown in FIG. 5A in a pre-formed condition;

FIG. 6B is a perspective view of the actuation sled shown in FIG. 6A ina formed condition with the knife blade and a dispensing needle of thewound closure material applicator assembly separated therefrom forillustrative purposes;

FIG. 6C is a perspective view of the formed actuation sled shown in FIG.6B with the knife blade and the dispensing needle mounted to the bladesupport portion thereof;

FIG. 6D is a perspective view of the dispensing needle and a portion ofthe conduit in an alternate embodiment;

FIG. 7 is a plan view of the preformed anvil plate which is mounted tothe anvil support beam of the anvil half-section of the surgicalstapling apparatus shown in FIG. 1A;

FIG. 8 is a cross-sectional view of the preformed anvil plate takenalong line 8-8 of FIG. 7;

FIG. 9 is a front end view of the preformed anvil plate illustrated inFIGS. 7 and 8;

FIG. 10 is a perspective view of the anvil half-section of the surgicalstapling apparatus of FIG. 1A with an enlarged localized view of adistal portion thereof illustrating the connective engagement betweenthe anvil plate and the anvil support beam;

FIG. 11 is an exploded perspective view of a lockout mechanism toprevent reactuation of the apparatus;

FIG. 11A is an enlarged cross-sectional view of the T-shaped member ofthe lockout mechanism;

FIG. 11B is a perspective view of the needle and the shank according toan alternate embodiment of the present disclosure wherein the needle isforked with two tines and each tine is directed to an opposing side ofthe shank;

FIG. 12 is an enlarged perspective view of the actuation channel havingan edge for engagement by the hook of the lockout mechanism;

FIGS. 13A and 13B are side views of the lockout mechanism illustratingits movement from a non-engaged to an engaged position;

FIG. 14 is a side elevational view in cross-section of the surgicalstapling apparatus of the present invention with the actuation sledsupporting the adhesive dispensing needle and disposed in a pre-actuatedproximal position;

FIG. 15 is a side elevational view in cross-section of the surgicalstapling apparatus of the present invention with the actuation sleddisposed in a partially advanced position;

FIG. 16 is a side elevational view in cross-section of the surgicalstapling apparatus of the subject application with the actuation sledadvanced to the distal end of the cartridge at the conclusion of astaple firing procedure;

FIG. 17 is a side elevational view in cross-section of the surgicalstapling apparatus of the subject application with the actuation sledadvanced to the distal end of the cartridge at the conclusion of astaple firing procedure and a dispensing needle located near the knifeblade;

FIG. 18A is a perspective view of an actuation sled including a woundclosure material applicator, in accordance with an alternativeembodiment, operatively connected thereto;

FIG. 18B is a top plan view of the actuation sled and applicator of FIG.18A;

FIG. 18C is a bottom plan view of the actuation sled and applicator ofFIG. 18A;

FIG. 19A is a perspective view of an actuation sled including a woundclosure material applicator operatively connected thereto, in accordancewith another embodiment;

FIG. 19B is a top plan view of the actuation sled and applicator of FIG.19A;

FIG. 19C is a bottom plan view of the actuation sled and applicator ofFIG. 19A;

FIG. 20A is a perspective view of an actuation sled including a woundclosure material applicator operatively connected thereto, according toyet another embodiment;

FIG. 20B is a top plan view of the actuation sled and applicator of FIG.20A;

FIG. 20C is a bottom plan view of the actuation sled and applicator ofFIG. 20A.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed surgical staplingapparatus will now be described with reference to the drawing figureswherein like reference numerals identify similar or identical elements.In the drawings and in the following description, the term “proximal”,as is traditional, will refer to the end of the apparatus which iscloser to the operator, while the term “distal” will refer to the end ofthe apparatus which is further away from the operator.

The present invention provides a surgical stapling apparatus having awound closure material applicator assembly which applies at least onebiological and/or synthetic biocompatible sealant, hemostat, adhesive,and combinations thereof (individually or collectively referred toherein as wound closure material), as well as surgical fasteners orstaples, for example, for providing hemostasis, tissue joining orwelding. The application of a wound closure material to the cut lineand/or staple line can provide short, i.e., temporary, and long-term,i.e., permanent, hemostasis and sealing, and reduce or prevent bleedingalong a knife cut line and/or staple line, while the stapling featuresprovide short and long-term tissue strength and hemostasis.

Since knife cut line and staple line bleeding is reduced or prevented,the surgical stapling apparatus of the present invention makes itpossible to expand the applicable range of specific staple sizes toinclude thinner or thicker staples used in highly vascularized tissue.For example, it is contemplated that relatively large-size staples couldbe used with the surgical stapling apparatus of the present invention tojoin thin, highly vascularized tissue.

Referring now to the drawings wherein like reference numerals identifysimilar structural elements, there is illustrated in FIGS. 1A and 1B asurgical stapling apparatus in accordance with a preferred embodimentand designated generally as reference numeral 10. Surgical staplingapparatus 10 includes a cartridge half-section 11 a and an anvilhalf-section 11 b.

Referring to FIGS. 2A, 2B and 3, stapling apparatus 10 includes a bodyportion 12 defining a handle for grasping and supporting staplingapparatus 10. A retaining channel 14 is mounted in an interior cavity 15of body portion 12 adjacent the distal end thereof. Retaining channel 14is dimensioned and configured to support a disposable loading unit 20,as illustrated in FIG. 4C.

As shown in FIG. 5A, disposable loading unit 20 includes a cartridge 22having tissue contacting or working surface 21, a plurality of slots 22c which support a corresponding number of surgical staples 24, aplurality of staple pushers or ejectors 26 adapted and configured toeject staples 24 from slots 22 c when acted upon by a staple drivingforce, and an actuation sled 28 which is mounted to translate throughcartridge 22 in a longitudinal direction to transmit a staple drivingforce to ejectors 26 and dispense a quantity of wound closure materialto be a target surgical site.

As seen in the figures, particularly in FIGS. 2A, 3, and 5A, surgicalstapling apparatus 10 includes a wound closure material applicatorassembly 2 operatively associated with surgical stapling apparatus 10.Wound closure material applicator assembly 2 includes a compressible (orsyringe-like, etc.) reservoir 4 (see FIG. 2A) in fluid communicationwith a needle 6 via a conduit 8. In use, wound closure materialapplicator 2 manually or automatically supplies a wound closure material“W”, or a component thereof, to a target surgical site. Conduit 8 entersbody portion 12 via an opening 9 and is configured for traversingapproximately the entire length of body portion 12 and cartridge 22,during firing of apparatus 10. Preferably, a distal portion of conduit 8is supported by actuation sled 28 and needle 6 is secured to, connectedto, or otherwise mounted on a portion of actuation sled 28, here onknife blade 36, in such a manner that the tip of needle 6 is oriented ina proximal direction. Conduit 8 preferably has sufficient slack toextend along the entire path of knife blade 36 for applying woundclosure material “W” along the entire or substantially the entire lengthof a knife cut line formed by knife blade 36 (see FIG. 16).

Reservoir 4, in one embodiment, is compressible and configured forplacement between cartridge half-section 11 a and anvil half-section 11b of apparatus 10. In this manner, as lever handle 100 is moved towardsbody portion 12 (see FIG. 2B) reservoir 4 is compressed. Compression ofreservoir 4 causes wound closure material “W” contained therein to beurged through conduit 8 and dispensed from needle 6. Preferably, woundclosure material “W” is dispensed during the staple firing procedure sothat wound closure material “W” is dispensed along the length of thestaple line and/or knife cut line.

In another embodiment, as shown by FIG. 2C, wound closure materialapplicator assembly 2 includes two reservoirs 3 a, 3 b, e.g., twosyringe-type non-compressible reservoirs, each in fluid communicationwith dispensing needle 6 (not shown) via at least one respective conduit8 a, 8 b. First reservoir 3 a stores one component of wound closurematerial “W” and second reservoir 3 b stores a second component of woundclosure material “W”. Preferably, the first and second reservoirs 3 a, 3b are identical for encasing an equal or appropriate volumetric amountof their respective component as compared to the other reservoir tomaintain a predetermined desired ratio of the first component to thesecond component, which is typically a 1:1 ratio. Reservoirs 3 a, 3 bare preferably actuated manually for dispensing their respectivecomponent Alternatively, depending on the components and situation, thetwo components can be joined and fed through a common conduit.

Preferably, wound closure material “W” is formed by the two componentsis fibrin glue or fibrin sealant, which acts as a hemostatic agent andas a tissue adhesive. Fibrin sealant is formed by the rapidpolymerization, which occurs when a solution of proteomic clottingfactors, such as fibrinogen, comes into contact with a solution of aproteomic catalyst, such as thrombin. This rapid polymerizationtypically commences within two seconds after the solutions initiallycontact one another, and it typically attains a soft set within tenseconds of contact. Because of the rapid polymerization upon intimateinteraction of fibrinogen and thrombin, it is important and preferableto maintain these two blood proteins separate until applied at theapplication site. Accordingly, it is preferred that wound closurematerial applicator assembly 2 supplies each blood protein separatelyfrom the other blood protein by using a separate conduit for eachprotein.

It is envisioned that wound closure material “W” can include one or acombination of adhesives, hemostats, sealants. Surgical biocompatiblewound closure materials which can be employed in or applied the surgicalinstruments, especially surgical staplers, include adhesives whosefunction is to attach or hold organs, tissues or structures, sealants toprevent fluid leakage, and hemostats to halt or prevent bleeding.Examples of adhesives which can be employed include protein derived,aldehyde-based adhesive materials, for example, the commerciallyavailable albumin/glutaraldehyde materials sold under the tradedesignation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats. Examples of commercially available hemostat materials arefibrinogen-thrombin combination materials under sold the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfate, and coagulants.

Cartridge 22 is preferably fabricated from liquid crystal polymermaterial, such as liquid crystal polymer resin, commercially availablefrom Plasticsnet.com under the trademark Xydar, although other materialsare contemplated. Cartridge 22 has a lip 23 which engages the retentionchannel 14 to prevent inward rotation of cartridge 22 (see FIG. 5B).

As best seen in FIG. 6A, actuation sled 28 is preferably monolithicallyformed from a single piece of sheet metal which is folded into thedesired structural configuration shown in FIGS. 6B and 6C. In thisconfiguration, actuation sled (staple actuator) 28 defines a baseportion 30, two upstanding cam wedges 32 and 34, and an upstanding shank35 which supports the knife blade 36 and the distal portion of conduit8. Conduit 8 and knife blade 36 are preferably spot welded to shank 35,although other known fastening methods, e.g., clamping, may be employed.As illustrated in FIG. 6B, a weldment port 37 and a winglet 39 areprovided to facilitate the proper alignment and cohesion of knife blade36 to shank 35 during fabrication. Actuation sled 28 can also benon-monolithically formed. Needle 6 is preferably formed to have agenerally semi-circular configuration (shown in FIGS. 6B, 6C) where ithas an arc, or radius of curvature, that is about 180°. Alternatively,in another embodiment, needle 6 is formed to have an arc, or radius ofcurvature, that is about 270° (see FIG. 6D).

Cam wedges 32 and 34 are staggered with respect to one another so thatone leads the other throughout the sled's translation through cartridge22. Longitudinal slots 22 a and 22 b accommodate the longitudinaltranslation of cam wedges 32 and 34, while a slot, or knife slot 22 d(see FIGS. 5A and 5B), i.e., knife track, accommodates the longitudinaltranslation of shank 35.

Base portion 30 of actuation sled 28 has a transverse slot 40 definedtherein which is dimensioned and configured to releasably retain anupturned flange 42 formed at the distal end of elongated actuationchannel 44 (FIG. 5A). When disposable loading unit 20 is placed intoretaining channel 14 and actuation sled 28 is disposed in itsproximal-most position, flange 42 releasably engages slot 40. Thus,movement of actuation channel 44 moves actuation sled 28. After astapling operation, when disposable loading unit 20 is removed fromretaining channel 14, flange 42 is easily disengaged from slot 40.

With continued reference to FIG. 5A, actuation channel 44 is defined bya base portion 45 and two parallel upstanding beams 46 and 48 ofelongate configuration. The distal ends of beams 46 and 48 are staggeredto match the staggered orientation of cam wedges 32 and 34,respectively. The proximal end of each beam projects rearwardly toengage a mounting block 49 that is associated with a firing knob 50. Apair of slots 52 (only one of which is shown) is formed in mountingblock 49 for receiving the proximal end of each of the upstanding beams46, 48 of actuation channel 44 and slots 52 are provided with detents 54for engaging apertures 56 in the beam ends to lockingly retain beams 46,48 in mounting block 49. In use, longitudinal movement of firing knob 50causes corresponding longitudinal translation of actuation channel 44and actuation sled 28.

Referring to FIGS. 2A and 4C, retention channel 14 includes a baseportion 60 and two upstanding parallel walls 62 and 64. Numericalindicia are imprinted on the walls 62, 64 of retention channel 14 toindicate the length of the staple line. Retention structures in the formof retention notches 66 a, 66 b are provided at the distal end of eachof walls 62, 64 to engage corresponding structures in the form ofprotuberances 67 provided on disposable loading unit 20. Similarly,slots 68 a and 68 b are provided at the distal end of each of walls 62,64 for engaging corresponding detents, such as detent 69 provided ondisposable loading unit 20. These structures inhibit lateral,longitudinal and perpendicular shifting of cartridge 22 (and disposableloading unit 20) within retaining channel 14. Ramped engagement slots 70a and 70 b are also defined in the opposed walls of retention channel 14for interacting with a pair of opposed protuberances 72 a and 72 b ofdisposable loading unit 20 (FIG. 5A) to guide disposable loading unit 20into retention channel 14 when loaded into the surgical staplingapparatus 10.

Referring again to FIG. 2A, surgical stapling apparatus 10 furtherincludes an elongate anvil support beam 80 which has a generallyU-shaped cross-sectional configuration. Proximal end portion 82 ofsupport beam 80 has a notched area 84 for engaging a pair ofcorresponding detents 86 (only one of which is shown), which extend intocavity 15 of body portion 12 adjacent the proximal end thereof. Detents86 are engaged when cartridge half-section 11 a and anvil half-section11 b are mated with one another. Distal end portion 88 of anvil supportbeam 80 is configured to support a preformed anvil plate 90 againstwhich staples 24 are driven and formed during a stapling procedure.

Referring to FIGS. 7 and 8, anvil plate 90 can be formed from a unitarypiece of metal and cold formed and stamped to define a plurality ofstaple forming recesses or cups 91. Each staple forming recess 91corresponds to a particular staple housed within cartridge 22. Anvilplate 90, as shown in FIG. 2A, is provided with two opposed tangs 92 aand 92 b which extend inwardly to engage complementary engagement slots93 b (only one is shown) in anvil support beam 80 during fabrication andassembly (see FIG. 10). The cross-sectional configuration of anvil plate90 is dimensioned to complement the cross-sectional geometry of supportbeam 80 (see FIG. 9). More particularly, a cavity, or knife track 97,which extends along the length of anvil plate 90, corresponds to asimilar channel formed in support beam 80. These areas accommodate shank35 (see FIGS. 6A-6C), and knife blade 36 and needle 6 as they translatedistally to form an incision in stapled body tissue during a staplingoperation.

A pair of rectangular apertures 95 a and 95 b are formed in anvil plate90 adjacent the proximal end thereof for receiving a pair ofcorrespondingly positioned flanges or projections 96 a and 96 b whichproject upwardly away from the tissue contacting surface (see FIGS. 2and 4C). The interaction between aperture 95 a, 95 b and flanges 96 a,96 b ensures that cartridge 22 and anvil plate 90 are properly alignedwith one another during a stapling procedure. Flanges 96 a, 96 b arespaced proximally of tissue stop portion 61 of retention channel 14.Portion 61 and distal edge 13 of body portion 12, best seen in FIG. 3,cooperate to prevent tissue from extending proximally.

Referring again to FIGS. 2A and 2B, anvil half-section 11 b of staplingapparatus 10 further includes clamping handle 100 which is used tosecurely clamp tissue between the staple forming surface of anvil plate90 and tissue contacting surface 21 of cartridge 22 (see FIG. 5A).Clamping handle 100 is pivotably mounted to anvil support beam 80 abouta transverse pivot pin, which is not shown in the drawings. A pair ofclamping hooks 102 a and 102 b depend from clamping handle 100 forinteracting with U-shaped clamping beam 104 supported within theinternal cavity defined in body portion 12.

When apparatus 10 is assembled prior to use, notched area 84 at proximalend 82 of anvil support beam 80 is engaged with cooperating detents 86in inner cavity 15 of body portion 12. Thereupon, anvil half-section 11b is mated with cartridge half-section 11 a, and clamping handle 100 isdisposed in the upright undamped position shown in FIG. 2B.Subsequently, when body tissue is disposed between the staple formingsurface of anvil plate 90 and tissue contacting surface 21 of cartridge22 (see FIG. 5A), anvil half-section 11 b is pivoted towards cartridgehalf-section 11 a, about the detents in body portion 12, such that thedistal ends of clamping hooks 102 a and 102 b are positioned immediatelyadjacent the proximal end of the base of U-shaped clamping beam 104.Concomitantly, flanges 96 a and 96 b engage apertures 95 a and 95 b inanvil plate 90 to ensure proper alignment of the anvil and thecartridge.

Then, to securely clamp the captured body tissue, clamping handle 100 ispivoted from the position illustrated in FIG. 1A to that which is shownin FIG. 1B. At such a time, clamping hooks 102 a and 102 b engage thebase of clamping beam 104, locking surgical stapling apparatus 10 in aclamped condition. During clamping, the captured body tissue to exerts acounter-force against the tissue contacting surface of cartridge 22 andthe fastener forming surface of the anvil plate 90, urging the twostructures apart. To overcome these forces and prevent the proximalportion 82 of anvil support beam 80 from bending, bearing surfaces aredefined within retention channel 14 to support the compressive forcesgenerated during clamping. In particular, as illustrated in FIG. 4A,opposed bearing shelves 110 a and 110 b are stamp formed in opposedwalls 62 and 64 of retention channel 14. The bearing shelves arepositioned to abut the medial section of anvil support beam 80 proximatethe clamping handle pivot point.

It may also be desirable to provide a locking mechanism to preventreactuation of the apparatus after it has been actuated. For example, alocking member 120 shown in FIG. 11 can be positioned in retainingchannel 114. Locking member 120 is biased to an upward engagementposition and each end extends through a window 141, 143 in channel 114.A T-shaped member 124 is positioned between cam wedges 132, 134 to biasthe hook portion 122 out of engagement with actuation channel 144. Headportion 126 of T-shaped member 124 (FIG. 11A) is initially retained inthe cartridge by a pair of detents in the cartridge which extend intothe knife slot. When the apparatus is actuated, head portion 126 ofT-shaped member 124 is in the knife slot. Needle 6 preferably is formedto have an angle of about 90° with respect to the bottom surface ofactuation channel 144 (FIG. 11). Further still, it is contemplated thatneedle 6 could be disposed to each of the sides of the shank, as shownin FIG. 11B. Preferably, needle 6 has a forked configuration with a pairof tines 6 a, 6 b where each tine 6 a, 6 b is directed towards anopposing side of shank 35.

A second pair of detents (not shown) at the distal end of the knife slotengages head portion 126 of T-shaped member 124 to hold it at the distalend of cartridge 122 when cam wedges 132, 134 are advanced to the distalposition. When actuation channel 144 is retracted from the post-actuatedposition to the pre-actuated position, T-shaped member 124 remainsforward allowing hook portion 122 to return to the upward position andextend through the window 141 in retaining channel 114 to engage edge143 (see FIGS. 12 and 13A) of actuation channel 144 to preventadvancement of the actuation channel.

FIGS. 13A and 13B illustrate movement of the locking member 120 from aninitial non-engaged position (FIG. 13A) out of engagement with actuationchannel 144 to an engaged position (FIG. 13B) in engagement withactuation channel 144 to prevent distal movement thereof.

Referring now to FIGS. 14-16, there is illustrated, in sequential order,a staple firing operation in which a plurality of staples are ejectedfrom cartridge 22 and driven against the working or staple formingsurface of anvil plate 90 while knife blade 36 cuts the tissue forming aknife cut line and needle 6 applies an adhesive into, on, or over theknife cut line, and, preferably also over one or more staple lines,especially where staple legs penetrate the tissue. In operation, priorto firing surgical stapling apparatus 10, actuation sled 28 is in theproximal-most position shown in FIG. 14. At such a time, knife blade 36and the distal portion of conduit 8 are enclosed or protected inprotective housing 25 formed adjacent the proximal end of disposableloading unit 20.

To fire the apparatus, firing knob 50 (see FIG. 2A) is moved in a distaldirection. Accordingly, as illustrated in FIG. 15, actuation channel 44drives actuation sled 28 distally into and through cartridge 22. Duringits distal translation, the angled leading surfaces of cam wedges 32 and34 sequentially contact ejectors 26, urging them in a directiontransverse to the direction of movement of actuation sled 28. As aresult, ejectors 26 push staples 24 from their individual slots 22 a,driving each staple into a respective staple forming cup 91 in anvilplate 90.

Sequential firing of the staples continues until actuation sled 28 isadvanced to the distal end of cartridge 22, at which time, all of thestaples once housed within cartridge 22 will have been ejected (see FIG.16) and the knife cut line formed by knife blade 36 and preferablyadjacent or all worked portions of the tissue have been supplied withwound closure material by wound closure material applicator assembly 2including particularly needle 6. Thereafter, firing knob 50 is retractedto its original position, the cartridge and anvil sections areseparated, and the spent disposable loading unit 20 is removed fromretaining channel 14. Subsequently, a new, fully loaded disposableloading unit 20 can be positioned in retaining channel 14 such that slot40 of actuation sled 28 engages flange 42 of actuation channel 44 toenable re-use of surgical stapling apparatus 10. Further, reservoir 4may be replaced or refilled prior to re-use of surgical staplingapparatus 10.

With reference to FIG. 17 there is shown a side elevational view incross-section of surgical stapling apparatus 10 with actuation sled 28advanced to the distal end of cartridge 22 at the conclusion of a staplefiring procedure and, in a variation of the embodiment, where dispensingneedle 6 is shown located on the same side as and over knife blade 36for dispensing adhesive on and/or in front of knife blade 36 during thestaple firing procedure. Needle 6 in FIG. 17 can have orifices along itsbottom surface to facilitate dispensing of wound closure material on, infront of, or near knife blade 36.

Turning now to FIGS. 18A-18C, an alternative embodiment of a portion ofa wound closure material applicator assembly, generally designated as100, is shown operatively connected to actuation sled 28. Wound closurematerial applicator assembly 100 includes a conduit 108 for transmittingwound closure material “W” from reservoir 4 (see FIG. 2A) and a needle106, having a substantially inverted “J-shape”, connected to a distalend of conduit 108. Needle 106 includes a hook portion 106 a configuredand dimensioned to hook over upstanding shank 35 such that a distal endof hook portion 106 a includes an orifice that is oriented substantiallydownwardly. In an alternative embodiment, conduit 108 can itself beadapted, e.g. with an orifice, to perform the function of needle 106.

Turning now to FIGS. 19A-19C, a further alternative embodiment of aportion of a wound closure material applicator assembly, generallydesignated as 110, is shown operatively connected to actuation sled 28.Wound closure material applicator 110 includes a conduit 118 fortransmitting wound closure material “W” from a source, e.g., reservoir 4(see FIG. 2A), and a needle 116 connected to a distal end of conduit118. Needle 116 includes a manifold head portion 116 a having twosubstantially “U-shaped” tips 116 b, 116 c with orifices (not shown).Head portion 116 a is preferably oriented such that tip 116 b hooks overupstanding shank 35 of actuation sled 28 and tip 116 c extends laterallyfrom upstanding shank 35 in a direction substantially opposite to tip116 b. In this manner, wound closure material “W” can be dispensed oneither side of upstanding shank 35.

Turning now to FIGS. 20A-20C, a still further alternative embodiment ofa portion of wound closure material applicator assembly, generallydesignated as 120, is shown operatively connected to actuation sled 28.Wound closure applicator 120 includes a conduit 128 for transmittingwound closure material “W” from reservoir 4 (see FIG. 2A) and a needle126 fluidly connected to a distal end of conduit 128. Needle 126includes a manifold head 126 a having three “U-shaped” tips 126 b, 126c, and 126 d with orifices (not shown). Head portion 126 a is preferablyoriented such that tips 126 b, 126 c hook over upstanding shank 35 ofactuation sled 28, and tip 126 d extends laterally from upstanding shank35 in a direction opposite tips 126 b, 126 c. In this manner, woundclosure material “W” can be more widely dispersed on either side ofupstanding shank 35. Alternatively, lip 126 c can be extended to, orover, or beyond the distal edge of knife blade 36.

While wound closure material applicators having single (FIGS. 1-18C),double (PIGS. 19A-19C) and triple (FIGS. 20A-20C) distribution tips areshown and described, it is understood and within the scope of thepresent disclosure that any number of distribution tips andconfigurations can be provided for distributing wound closure material“W” along the staple line and/or the knife cut line.

While the distribution tips of FIGS. 18A-20C, have been shown as beingoriented in a substantially downward direction, it is envisioned thatthe distribution tips can be oriented in a proximal, distal downward orupward direction or any combination thereof.

It is envisioned that each conduit 108, 118 and 128 shown herein caninclude at least one, preferably a plurality, of apertures 108 a, 118 a,and 128 a, respectively, formed along a length thereof. Preferably,apertures 108 a, 118 a, and 128 a are formed along the upper side andalong the lateral sides thereof. In this manner, when wound closurematerial “W” is urged through conduits 108, 118, and 128, a quantity ofwound closure material “W” is dispensed from apertures 108 a, 118 a, 128a along staple line and/or knife cut line.

Although FIGS. 18A-20C show a conduit disposed to the side of shank 35of actuation sled 28, it is preferred that the conduit be disposed alongthe proximal or rear edge of the shank, sled, or like structure. Theconduit and/or needle can be secured, connected to, or mountedpermanently or removably on or to a sled, knife blade, or blade carrierstructure in any suitable manner. Relative conduit and needle lengthsand configurations can be modified to suit the application.

In any or all of the embodiments, or combinations thereof disclosedherein, at least a portion of the conduit can have openings or orificesalong its side surface and/or its top surface and/or, especially, alongits bottom surface such that wound closure material can be dispenseddirectly into and about the knife cut line, for example, as the conduitconnected, for example, to actuation sled 28, with or without a needle,is moved axially along the cartridge and/or anvil.

It is to be understood that if openings are provided in a conduit,depending on the wound closure material and use, the openings may haveto be temporarily previously sealed until it is desired to dispense thewound closure material through the conduit. This would apply, e.g. ifthe wound closure material were in the conduit or the needle, orapplicator, such that its orifice(s) would need to be sealed. The sealcan be burst by the fluid pressure applied by compression of reservoir 4or other suitable, e.g. hydraulic or pressurized, system.

It is to be understood that the dispensing of wound closure material “W”can be as a fluid spray of any suitable volume, including a mist,applied temporarily, continuously, or continually. Particulate material,e.g. a fine powder is contemplated to be a fluid within the scope ofthis disclosure.

It is provided that a number of different wound closure materials “W”can be dispensed by wound closure material applicator assembly 2 or acombination of the number of different wound closure materials “W”. Thewound closure material dispensed by wound closure material applicatorassembly 2 can, for example, be an astringent, such as a sulfate ofaluminum, which causes small blood vessels to close and helps the bloodto coagulate. It is provided that wound closure material “W” can be anastringent provided in the material commercially available under thetrade designation No Nix Styptic Pencils from Requa™, Inc.

Although the subject apparatus has been described with respect topreferred embodiments, it will be readily apparent, to those havingordinary skill in the art to which it appertains, that changes andmodifications may be made thereto without departing from the spirit orscope of the subject apparatus.

1-22. (canceled)
 23. A surgical stapling apparatus for joining bodytissue, comprising: a staple anvil having a knife track; a staplecartridge adjacent the staple anvil, the staple cartridge and stapleanvil being juxtaposable with one another, the staple cartridgeincluding a plurality of surgical staples arranged in linear rows, thestaple cartridge having a knife slot extending between two of the linearrows; a staple actuator having at least one cam wedge for ejecting thestaples; a driving member for distally translating the staple actuatorto eject the staples from the staple cartridge and drive the staplestoward the anvil; a knife blade arranged to translate distally along thelinear rows of staples with the staple actuator; and a wound closurematerial applicator assembly, including a conduit having a distributiontip defining an orifice, the conduit being attached to the stapleactuator and arranged so that the orifice faces proximally, the woundclosure material applicator assembly including a source of wound closurematerial.
 24. The surgical stapling apparatus according to claim 1,wherein the staple cartridge defines at least two linear rows of stapleson either side of the knife slot.
 25. The surgical stapling apparatusaccording to claim 1, wherein the knife blade is attached to the stapleactuator.
 26. The surgical stapling apparatus according to claim 1,wherein the staple actuator has an upstanding shank for supporting theknife blade.
 27. The surgical stapling apparatus according to claim 1,wherein the conduit has a plurality of apertures defined along a side ofthe conduit.
 28. The surgical stapling apparatus according to claim 1,wherein the source of wound closure material includes a first reservoirhaving a first component of the wound closure material, and a secondreservoir having a second component of the wound closure material. 29.The surgical stapling apparatus according to claim 1, wherein theconduit has a second distribution tip.
 30. The surgical staplingapparatus according to claim 7, further comprising a clamping handle,the clamping handle being movable to move the staple cartridge andstaple anvil into a clamping position.
 31. The surgical staplingapparatus according to claim 1, wherein the staple actuator is removablyattached to the driving member and contained in the staple cartridge,the staple cartridge being replaceable.
 32. The surgical staplingapparatus according to claim 1, wherein the source of wound closurematerial is selected from the group consisting of a syringe and acompressible reservoir.